Kornimate/medical-research-clean huggingface dataset:
bionenergetic balance during cvvh

Conditions: Acute Kidney Injury; Continuous Venovenous Hemofiltration; Energy Metabolism; Resting Energy Expenditure; Nutrition Therapy

Summary: the bioenergetic balance is the sum of energy exchanged during crrt and is mostly defined by citrate glucose and lactate. when crrt was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). during continuous venovenous hemofiltration (cvvh), a subgroup of crrt which is performed with the newer dialysis fluids without lactate or glucose as advocated by the kdigoguidelines, glucose and in a minor way lactate mostly induce a loss of energy. the first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted. also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. how this predicting equation and other existing predicting equations agree with the measured ree has not been validated yet. the second aim is to determine how predictive equations correlate with measured ree in patients treated with cvvh.


Eligibility criteria:
inclusion criteria: * patients admitted to the adult icu (01/01/2021-30/09/2022) * at least one indirect calorimetry measurement (ventilator) or calculation based on harris benedict or 25kcal/kg/day * combined with bio energetic balance measurement * receiving cvvh during intensive care stay exclusion criteria: * patients admitted outside of the inclusion period will be excluded * the absence of an indirect calorimetry measurement (ventilator) or calculation - based on the harris benedict or 25kcal/kg/day formula or the absence of a bio energetic balance measurement * the absence of cvvh during intensive care stay * pediatric (intensive care unit) patients
patient satisfaction with virtual postoperative visit

Conditions: Post-Op Complication

Summary: this is a prospective, randomized study designed to evaluate the effects of different initial postoperative follow-up modalities. given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded. to reduce bias that may occur due to each surgeon's personal preference for postoperative follow-up modality, the surgeons (rather than individual subjects) will be randomized to one of two postoperative follow-up modality groups (traditional or virtual).


Eligibility criteria:
inclusion criteria: * \> 18 years old * \< 60 years old * undergoing knee arthroscopy procedure exclusion criteria: * \< 18 years old * \> 60 years old
long-term safety of dvs-233 sr in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the study evaluated the long-term safety of desvenlafaxine succinate (dvs) slow release (sr) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (mdd). the study also evaluated the long-term response of subjects receiving dvs sr for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).


Eligibility criteria:
inclusion criteria: * outpatients who have completed double-blind therapy in a phase 3 dvs-233 sr short-term study for the indication of mdd, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study. * sexually active individuals participating in the study must use a medically acceptable form of contraception during the trial and for at least 15 days after the last dose of study drug. exclusion criteria: * clinically important abnormalities on baseline physical examination, or any unresolved clinically significant abnormalities on ecg, laboratory test results, or vital signs recorded in a previous phase 3 dvs-233 sr short-term study for the indication of mdd. any exception must be discussed with and granted by the sponsor. * significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention. * presence of clinically important hepatic or renal disease or other medical disease that might compromise the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension, seizure disorder, myocardial infarction, neurologic disorder, acute illness, neoplastic disorder).

Keywords: major depressive disorder desvenlafaxine antidepressant
flaxseed supplement in treating patients with locally advanced or metastatic non-small cell lung cancer undergoing chemotherapy and radiation therapy

Conditions: Lung Cancer; Radiation Toxicity

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. flaxseed may help protect normal cells from the side effects of radiation therapy. purpose: this randomized phase i trial is studying the side effects of flaxseed supplement in treating patients with locally advanced or metastatic non-small cell lung cancer undergoing chemotherapy and radiation therapy.

objectives: primary * to assess the feasibility of dietary flaxseed (fs) supplementation in patients undergoing definitive chemoradiotherapy for locally advanced or metastatic non-small cell lung cancer. * to collect toxicity and tolerability data on dietary fs supplementation during definitive chemoradiotherapy. secondary * to validate urinary and serum markers of oxidative stress and fs lignan levels as surrogates of the bioavailability of fs in these patients. * to determine if a dose response to daily ingestion of 20 g or 40 g of fs can be observed in plasma lignan levels and urinary markers of oxidative stress. outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks. * arm ii: patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks. blood and urine samples are collected periodically for biomarker studies. after completion of study treatment, patients are followed up for 1 month.

Eligibility criteria:
disease characteristics: * diagnosis of non-small cell lung cancer * locally advanced or metastatic disease * requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy * total planned radiation dose to gross disease 60-80 gy patient characteristics: * no diagnosis of disease of the gastrointestinal (gi) system, liver, or kidneys that could result in altered metabolism or excretion of the study medication (e.g., history of major gi tract surgery, gastrectomy, gastrostomy, or bowel resection) * no history of chronic gi disorders (e.g., ulcerative colitis, regional enteritis, or gi bleeding) * no known hypersensitivity to flaxseed or any of its metabolites or to wheat products prior concurrent therapy: * see disease characteristics * see patient characteristics * more than 14 days since prior and no concurrent investigational drugs * more than 14 days since prior and no concurrent amifostine or mucomyst (n-acetylcysteine) * no prior thoracic radiotherapy * no prior or other concurrent flaxseed, flax-containing products, soybeans, or soy-containing products * no other concurrent dietary supplements, such as herbals or botanicals * vitamins or multivitamins, including calcium and vitamin d, are allowed

Keywords: radiation toxicity stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer recurrent non-small cell lung cancer stage iv non-small cell lung cancer
the relationship between fibromyalgia syndrome parameters with disease-pain severity and the quality of life

Conditions: Fibromyalgia Syndrome; Anxiety Disorders; Depressive Disorder

Summary: in this study, the investigators aim to evaluate the relationship between disease severity, quality of life, anxiety and pain level in patients diagnosed with fibromyalgia syndrome (fms) with the parameters according to the american college of rheumatology (acr) 2016 diagnostic criteria. according to the 2016 acr diagnostic criteria, there are 2 separate scales: widespread pain index (wpi) and symptom severity (ss) . the relationship between these 2 parameters and the fibromyalgia impact questionnaire, the world health organization short quality of life questionnaire, and the mcgill melzack pain questionnaire and beck anxiety questionnaire will be examined.

the aim of this study is to observe the relationship between the wpi and ss parameters in the acr 2016 criteria for fibromyalgia, separately, with the severity of the disease, pain level, quality of life and anxiety level. accordingly, the investigators aim to evaluate whether wpi or ss has priority in assessing the severity of the disease. there is no study in the literature comparing the importance of the 2016 acr diagnostic parameters on the disease effect. in this context, this study will be the first study in the literature and will be very valuable. patients visiting the outpatient clinic with fms diagnosis will be evaluated. patients will be asked to fill the world health organization short quality of life questionnaire, and the mcgill melzack pain questionnaire and beck anxiety questionnaire . the patients will be assed by an experienced physical medicine and rehabilitation specialist for ss and wpi scores.

Eligibility criteria:
inclusion criteria: * diagnosed as fms according to acr 2016 criterias exclusion criteria: * history of malignity * history of rheumatological disease
prevalence and long term effects of frailty in elderly intensive care patients

Conditions: Frailty; Critical Illness

Summary: the primary aim is to study change of critical frailty scale (cfs) and health related quality of life (eq-5d-5l) in a long-term follow-up of icu survivors. we aim to identify important icu related predictors for change in cfs and eq-5d-5l in long term follow up (1 yr). secondary aim is to investigate how cfs pre-admission is related to intrahospital treatment intensity level, severity score and mortality.

this is a multi-centre norwegian observational, prospective multicenter norway coordinated from university hospital north norway, tromso. the study is approved by the regional committee for medical research ethics northern norway. the following scores will be assessed by asking the patient and relative during icu stay: cfs, eq5dl before current critical illness. the following demographic and clinical data will be retrieved from the medical records: comorbidity before critical illness, reasons for icu admission, daily severity score (sofa- score), length of mechanical ventilation, dialysis, tracheostomy, habitat before and after icu treatment, icu and hospital length of stay, complications retrieved during intensive care treatment, mortality, limitation of treatment. the patients will be followed up with telephone interview after hospital discharge for evaluation of: comorbidity, cfs, eq5ddata for all sites are collected and managed using redcap electronic data capture tools. three research nurses will do the follow up with telephone interviews on all sites and record the data in redcap. we aim to enroll 300 patients before 31. des 2024.

Eligibility criteria:
inclusion criteria: * \>= 65 years * ≥ 24 hours mechanical ventilation * written informed consent from patient or next of kin exclusion criteria: * readmission of patient included in the study * not possible to obtain a valid cfs or and eq-5d-5l at admission or follow-up of cfs because of social context or language.

Keywords: clinical frailty scale mechanical ventilation elderly eq-5d-5l
online phn cbt for ppd

Conditions: Postpartum Depression

Summary: the primary objective of this study is to determine if online group cbt for ppd delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating ppd, b) reducing relapse and recurrence, c) improving common comorbidities and complications of ppd including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.

a prospective, 1-site, parallel group, rct (1:1 ratio) in which outcome assessors and data analysts will be blinded to maternal treatment will be used to compare online phn-delivered group cbt for ppd to postnatal care as usual. the primary objective of this study is to determine if online group cbt for ppd delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating ppd, b) reducing relapse and recurrence, c) improving common comorbidities and complications of ppd including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective. women in the treatment group will participate in a 9-week group cbt intervention for ppd delivered via zoom by two public health nurses. it consists of 9 weekly 2-hour sessions where core cbt skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.

Eligibility criteria:
inclusion criteria: * eligible women will be \>18 years of age, understand and speak english (so that they can participate in the cbt group and complete study measures), have an epds score between of 10 or more and meet diagnostic criteria for current major depressive disorder on the mini international neuropsychiatric interview-plus (mini-plus). they will also all be within 12 months of delivering an infant. exclusion criteria: * in order to increase the relevance and generalizability of our findings, women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder. these are predictors of significant difficulty participating in therapy groups and/or non-response to cbt.
a study of ritonavir-boosted danoprevir and ro5024048 in different combinations in null responder or treatment-naïve patients with chronic hepatitis c and compensated cirrhosis

Conditions: Hepatitis C, Chronic

Summary: this open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with ro5024048 added to the combination treatment in prior null responder patients with chronic hepatitis c genotype 1 or 4 and compensated cirrhosis. all patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. prior non-responders will receive ro5024048 1000 mg orally bid additionally. anticipated time on study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, 18 to 65 years of age inclusive * chronic hepatitis c, genotype 1 or 4 * cohort 1: treatment-naïve for hepatitis c * cohort 2: prior null responder to treatment with approved doses of pegylated interferon plus ribavirin * liver biopsy confirming cirrhosis * compensated cirrhosis (child-pugh a) exclusion criteria: * pregnant or lactating women or male partners of women who are pregnant * history or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices) * cohort 2: patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response * history of clinically significant cardiovascular or cerebrovascular disease
an open-label, dose escalation multi-center study in patients with advanced cancer to determine the infusion rate effect of asa 404 with paclitaxel plus carboplatin regimen or docetaxel on the pharmacokietics of free and total asa404

Conditions: Metastatic Cancer With Impaired Renal Function; Metastatic Cancer With Normal Renal Function

Summary: the purpose of this study is to determine the effect of the asa404 infusion rate and co-administrating asa404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (pk) of free and total asa404.


Eligibility criteria:
inclusion criteria: * patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy * patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate * creatinine clearance according to cockcroft-gault formula : normal \> 80 ml/min, mild 50-80 ml/min, moderate 30-\<50 ml/min * a minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies * potassium, calcium, magnesium and phosphorus values within the normal range * body mass index (bmi) must be within the range of 18 and 30 exclusion criteria: * patients having cns metastases, must have a ct or mri of the brain performed to rule out cns metastases * patients with leptomeningeal disease metastases * radiotherapy \</- weeks prior to starting study drug * major surgery \</ 4 weeks prior to the start of study * administration of cyp1a2 and cyp3a4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced or metastatic cancer refractory core phase extension phase dose escalation standard chemotherapy doctaxel paclitaxel carboplatin safety tolerability
36-month special drug use surveillance on frequency of bone fractures with sodium risedronate 75 mg tablets

Conditions: Osteoporosis

Summary: the purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.

this special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets in osteoporosis patients in daily medical practice. the usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 ml) of water once monthly after waking.

Eligibility criteria:
inclusion criteria: osteoporosis patients who meet all the following criteria: 1. patients with 1 to 4 confirmed vertebral body fractures in the t4-l4 region by thoracic and lumbar spine x-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets) 2. male and postmenopausal female patients aged 50 years or older 3. ambulatory outpatients exclusion criteria: -

Keywords: pharmacological therapy
acceptance and commitment therapy (act) adapted for women with infertility-related distress

Conditions: Infertility, Female

Summary: this rct will test the effect of a 7-week self-help act-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.

ninety women with infertility living in canada and the united states will be recruited. they will be emailed seven weekly 15-minute videos, each providing instructions on a new acceptance and commitment therapy-based technique that addresses the impact of infertility on psychological inflexibility and distress. fertility-related quality of life and psychological flexibility will be measured before and after the program. outcomes will also be measured at one-month follow-up. feedback about how to improve the program will also be collected.

Eligibility criteria:
inclusion criteria: * has been trying to get pregnant for 12+ months and has failed or is currently undergoing fertility treatments * lives in canada or the united states * reports a high level of distress related to infertility, as indicated by a fertiqol score below 71 exclusion criteria: * is currently experiencing active suicidal ideation, as indicated by a score of 7 or above on the suicide behaviours questionnaire - revised (sbq-r)
rotateq reexamination study (v260-037)

Conditions: Gastroenteritis Rotavirus

Summary: this survey is conducted for preparing application materials for re-examination under the pharmaceutical affairs laws and its enforcement regulation, its aim is to reconfirm the clinical usefulness of rotateq through collecting the safety information according to the re-examination regulation for new drugs.


Eligibility criteria:
inclusion criteria: * infants who are vaccinated with rotateq for the prevention of rotavirus gastroenteritis within local labeling will be included exclusion criteria: * participants who are vaccinated with rotateq before study start * participant who has a contraindication to rotateq according to the local label

Keywords: gastroenteritis rotavirus
earlier mobilization post acute thrombolysis

Conditions: Stroke; Stroke, Acute; Stroke, Ischemic

Summary: this is a phase iii trial trying to determine whether 12-hour bed rest following iv thrombolysis therapy (i.e. tpa) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified rankin scale (mrs) at 90 days post bed rest.


Eligibility criteria:
inclusion criteria: * age 18 years or older * received intravenous tpa for a clinical diagnosis of acute ischemic stroke * patient and/or legally authorized representative provide consent exclusion criteria: * venous thromboembolism present at symptom onset * pneumonia present at symptom onset * stemi at symptom onset * positive troponins at symptom onset according to local values * bone fracture at symptom onset * treatment includes or anticipated to include thrombectomy * intubation anticipated or occurred * symptomatic intracranial hemorrhage (defined as increase in nihss by 4 points or more accompanied by ph2 hemorrhage on imaging) at the time of screening. * pre-screening systolic blood pressure \< 110 mmhg * resting pulse oximetry \< 92% (with or without supplemental oxygen) * neurological worsening (defined as nihss increase of 4 points compared to initial score) prior to screening. * baseline modified rankin scale score \> 2 * known pregnancy * patient not anticipated to survive 3 months * patient not anticipated to follow-up at 3 months

Keywords: mobilization thrombolysis ischemia cerebrovascular disorders brain diseases recovery